Diagnostic Potential of UCHL1 in Acute Decompensated Heart Failure

NCT04999995 | Completed

• 2 other identifiers: CARA-005-19F1569386
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

Autophagy is considered an important component of Heart failure progression. Deubiquitination enzymes play an important role in autophagy. An important regulatory process within the autophagy pathway is ubiquitination. Ubiquitination targets proteins for degradation. On the contrary, de-ubiquitinating proteins (such as UCHL1) reverses this process. Studies have demonstrated deubiquitination to be linked to certain pathological processes, such as heart failure. UCHL1 will be examined as a potential marker of disease progression in acute decompensated heart failure.

Conditions

Heart Failure; Dyspnea; Cardiac

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy

  Assess accuracy of UCHL1 to diagnose ADHF as well as correlate with improvement

  30 days

Study Arms (3)

HFrEF

Patients admitted with acutely decompensated HFrEF.

HFpEF

Patients admitted with acutely decompensated HFpEF.

Non-HF Dyspnea

Patients admitted with acute dyspnea without evidence of HF.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Single Center VA patients with systolic and diastolic HF, acutely decompensated (ADHF), and a comparator cohort with non-HF dyspnea of non-cardiac origin (the control) will be recruited for this study

You may qualify if:

• Able to give informed consent
• Age \>= 18 years

You may not qualify if:

• Mortality during inpatient observation
• Presence of acute stroke (ischemic or hemorrhagic)
• Presence of intracranial hemorrhage
• History of acute stroke (ischemic or hemorrhagic) or intracranial hemorrhage within the preceding 6 months
• Presence of decompensated liver disease (elevated ALT/AST; ascites; Acute variceal bleeding; or hepatic encephalopathy)
• Presence of sepsis
• Presence of severe hyponatremia (Serum sodium \< 130 meq/L)
• Active malignancy (undergoing chemotherapy, radiation therapy, or planned surgical intervention)
• SARS-CoV-2 positive during the current admission

Sponsors & Collaborators

• VA Office of Research and Development: lead
• William Jennings Bryan Dorn VA Medical Center: collaborator

Study Sites (1)

Wm. Jennings Bryan Dorn VA Medical Center, Columbia, SC

Columbia, South Carolina, 29209-1638, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine and plasma/serum

MeSH Terms

Conditions

Heart Failure; Dyspnea

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Taixing Cui, PhD MB

  Wm. Jennings Bryan Dorn VA Medical Center, Columbia, SC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2021
• First Posted: August 11, 2021
• Study Start: June 1, 2021
• Primary Completion: March 17, 2025
• Study Completion: March 17, 2025
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

US (1)